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fMRI of the Brainstem in Migraine Sufferers and Controls. Does Iron Deposition Correlate With Progression of Disease?

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ClinicalTrials.gov Identifier: NCT00868556
Recruitment Status : Completed
First Posted : March 25, 2009
Last Update Posted : January 5, 2010
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:

This is a 2 visit research study for patients with or without a diagnosis of migraine. Participants will be administered informed consent, have a medical history taken and a physical examination performed, and complete 3 questionnaires at the first visit. The participants will have a functional MRI performed after completion of Visit 1. Study stipends will be given for each completed research visit.

The purpose of this study is to potentially identify risk factors and/or biomarkers (which are differences in the brain structures)by comparing the brain MRI scans of migraine sufferers to brain scans of control persons to attempt to identify migraine progression using the functional MRI scans.


Condition or disease
Episodic Migraine Chronic Daily Migraine

Detailed Description:

At Visit 1, patients in 3 diagnostic arms,(consisting of subjects with episodic migraine, chronic daily migraine or non-migraineurs/controls), of 11 subjects each, will be consented and then have a physical exam, medical history and current medication use documented. Each of these enrolled subjects will have a PRIME MD assessment administered, and will complete the MIDAS and ASC-12 questionnaires.

At Visit 2 these same subjects will have an fMRI performed.

Subjects will be greater than age 18, have the appropriate diagnoses, be able to be consented and not be pregnant or have an inability to have the fMRI performed (have implanted metal devices, have severe claustrophobia).


Study Design

Study Type : Observational
Actual Enrollment : 33 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: fMRI of the Brainstem in Migraine Sufferers and Controls. Does Iron Deposition Correlate With Progression of Disease?
Study Start Date : January 2009
Primary Completion Date : August 2009
Study Completion Date : August 2009


Groups and Cohorts

Group/Cohort
1 episodic migraine sufferers
2 chronic migraine sufferers
3 non migraine sufferers (controls)


Outcome Measures

Primary Outcome Measures :
  1. assess anatomical changes with emphasis in iron deposition in brainstem structures of migraineurs and controls [ Time Frame: within a month after consent is obtained ]

Secondary Outcome Measures :
  1. correlate outcomes with headache surrogates (frequency, time since onset and age) [ Time Frame: within one month after enrollment ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
11 episodic migraine sufferers, 11 chronic migraine sufferers, 11 non-migraine sufferers
Criteria

Inclusion Criteria:

  • adult episodic, chronic or non-migraine sufferers able to consent

Exclusion Criteria:

  • contraindication to MRI such as severe claustrophobia and implanted devices such as neurostimulators, pacemakers, aneurysm clips, etc
  • pregnancy
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00868556


Locations
United States, Ohio
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
The Cleveland Clinic
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Stewart J Tepper, MD The Cleveland Clinic
More Information

Publications:
Responsible Party: Stewart Tepper MD, PI, Cleveland Clinic Foundation
ClinicalTrials.gov Identifier: NCT00868556     History of Changes
Other Study ID Numbers: V81708
Merck Grant IISP 36047
First Posted: March 25, 2009    Key Record Dates
Last Update Posted: January 5, 2010
Last Verified: March 2009

Keywords provided by The Cleveland Clinic:
fMRI scans
episodic migraine sufferers
chronic migraine sufferers
non migraine sufferers (controls)

Additional relevant MeSH terms:
Migraine Disorders
Siderosis
Headache Disorders, Primary
Headache Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Pneumoconiosis
Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases
Lung Injury
Occupational Diseases